MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 3058

Device Problems Unintended Collision (1429); Energy Output Problem (1431)

Patient Problems Incontinence (1928); Discomfort (2330); Insufficient Information (4580)

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and gastr ointestinal/pelvic floor.It was reported that  therapy is working as since received implant only experienced about 20-25% improvement in symptom control.The patient said that after finishing, it feels like she has to do it again and again and is leaking a little.The patient said he has to use a liner.The patient said that when going for a walk or out of the house, she has to go constantly and also take some liquid, and when bending over, the feces just come out.  it was also said that when the patient increases the setting, the shape of the feces has changed more, like a corkscrew, and is uncomfortable.When asked, there were no changes; however, the daughter said that the patient did fall (when walking the dog) about six months ago. reviewed therapy information and general programming guidance.During call, patient switched programs and adjusted settings.Confirmed stimulation in the bicycle seat area and comfort.Patient will maintain stimulation level and will continue to track symptoms.Based on results, if, after trying all programs, the patient still hasn't experienced at least 50% or greater symptom control, they should schedule reprogramming session at hcp office and inquire about adding custom programs.Patient said hasn't' been seen at hcp office since post - op appointment.Additional information was received from the patient on.2024-03-26.Patient's daughter called back with the patient, and they reported that the patient's issues were still going on and that the patient was having a lot of random fecal incontinence, which was increasing day by day and week by week.Patient stated that they'd tried every program setting and that if they were too low, it didn't help, but when they went higher, it would hurt in their groin and would only work for 12¿14 hours, and then all of a sudden their symptoms of fecal incontinence would come back.Patient stated that if they bent over to pick something up, they'd have an accident.Patient services reviewed programming and stimulation considerations with the patient.The patient's daughter also confirmed that the patient had fallen a few times over the past year.Patient services reviewed with the patient that if they'd tried every program and each setting that helped for a bit and then stopped helping and they'd had falls in the past year, they should follow up with their health care provider (hcp) to check the implanted system and to potentially discuss adding additional programs.Patient and daughter stated they would call the patient's managing health care provider (hcp) on record.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19134229
• MDR Text Key: 341155451
• Report Number: 3004209178-2024-09311
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/18/2024
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female